September 20, 2024

Dear Colleague,

While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.

Updates

• September 20, 2024 - FDA Approves First Treatment for Niemann-Pick Disease, Type C
• September 18, 2024 - FDA Announces Animal and Veterinary Innovation Centers Partnerships
• September 17, 2024 - FDA Releases Results of Sampling of Retail Dairy-Free Dark Chocolate and Chocolate-Containing Products for Milk Allergen
• September 17, 2024 - FDA Roundup
• September 16, 2024 - FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology
• September 13, 2024 - FDA Takes Action Against Unauthorized E-Cigarettes Promoted at Industry Trade Show
• September 13, 2024 - FDA Roundup
• September 10, 2024 - Evaluating FDA Human Foods and Tobacco Programs

Consumer Updates

The Facts on Tampons—and How to Use Them Safely

If you use tampons during your period (or menstruation), it’s important to know how to use them safely. Consider this important information from the FDA — and please share this information with other people who may use these products.

Guidance Documents

Chemical Analysis for Biocompatibility Assessment of Medical Devices

This draft guidance document provides the FDA’s recommendations on analytical chemistry testing to assess the biocompatibility of medical devices. Chemical characterization is one approach that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device.

Conducting Clinical Trials With Decentralized Elements

This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. In this guidance, a decentralized clinical trial refers to a clinical trial that includes decentralized elements where trial-related activities occur at locations other than traditional clinical trial sites.

Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice

As part of FDA’s Real-World Evidence (RWE) Program, this draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice.

CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies

This guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions. This guidance describes the options for soliciting early input from CVM and the process for submission of components of the CMC technical section.

Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs

This guidance provides recommendations to sponsors who are planning global clinical development programs for drugs intended to treat cancer, on improving the evidence obtained from one or more multiregional clinical trials (MRCTs) intended to support a marketing application.  This guidance expands on principles described in FDA’s existing guidance documents related to this topic by providing additional recommendations for the planning, design, conduct, and analysis of an oncology MRCT that may facilitate FDA’s assessment of applicability of the data to the U.S. population with the cancer being investigated and to U.S. medical practice.

Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)

The FDA is issuing this guidance to assist persons submitting cigarette plans for cigarette packages and cigarette advertisements, as required by the Family Smoking Prevention and Tobacco Control Act (TCA), amending the Federal Cigarette Labeling and Advertising Act (FCLAA). This guidance provides recommendations related to 21 CFR 1141 and the FCLAA requirements regarding the submission of cigarette plans for cigarette packages and cigarette advertisements.

Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised)

FDA is issuing this guidance to help small businesses understand and comply with FDA’s final rule, “Required Warnings for Cigarette Packages and Advertisements,” which establishes new required cigarette health warnings for cigarette packages and advertisements. The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (TCA) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of the new required warnings.

View all Official FDA Guidance Documents and other Regulatory Guidance

You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

Webinars and Virtual Workshops

Clinicians Connect: Conversations with FDA's Chief Medical Officer

September 25, 2024; 11a.m. - 12 p.m. ET

Are you a health care professional and want to learn more about the current state of the opioid crisis and what we can do to prevent drug overdoses and reduce deaths?  Presenters will provide the latest information on the drug overdose crisis, how government agencies are working together to help health care professionals, and resources you can use today in your practice, including free training.

Measuring Toxicity in Reproductive Organs During Oncology Drug Development: An FDA - ASCO Virtual Workshop

October 1 & 8, 2024

Day 1: Tue, Oct 1; 1 - 5 p.m. ET
Day 2: Tue, Oct 8; 9 a.m. - 12:15 p.m. ET

Cancer survival has improved in recent decades, increasing the importance of studying the impact of anti-cancer treatments on quality of life such as on gonadal function and fertility. Incidence of cancer is also increasing in younger patients who are in their reproductive years. Many of these patients receive treatments that could produce reproductive toxicity.

View Upcoming FDA Meetings, Conferences and Workshops

Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov.